Internal pedicle insulator

ABSTRACT

A pedicle insulator implant is designed to protect the nerves and surrounding tissue from injury by pedicle screws or other surgical devices and instruments. The implant is configured to shield a fixture, reduce nerve root irritation, and diminish loosening of the fixture, when the fixture is implanted into the void of a target site. The implant includes features for stabilizing and securing the implant within the void at the target site. For example, in one embodiment, the implant includes one or more ridges and one or more teeth sections that stabilize the implant against rotational and extractive forces that could disturb the implant.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Non-Provisional patentapplication Ser. No. 16/656,067 filed Oct. 17, 2019, the entirety ofwhich is hereby incorporated herein by reference for all purposes.

This application is also related to: U.S. patent application Ser. No.16/511,946, filed Jul. 15, 2019, entitled “INTERNAL PEDICLE INSULATOR,”which is a continuation of U.S. patent application Ser. No. 15/975,308,filed May 9, 2018, now U.S. Pat. No. 10,390,860, entitled “INTERNALPEDICLE INSULATOR,” which is a continuation of U.S. patent applicationSer. No. 14/723,620, filed May 28, 2015, now U.S. Pat. No. 9,993,268,entitled “INTERNAL PEDICLE INSULATOR” which claims the benefit of andpriority to U.S. Provisional Patent Application No. 62/003,978, entitled“INTERNAL PEDICLE INSULATOR”, filed May 28, 2014; and

U.S. patent application Ser. No. 11/712,257, filed Feb. 28, 2007, nowU.S. Pat. No. 8,728,132, entitled “INTERNAL PEDICLE INSULATOR APPARATUSAND METHOD OF USE,” which is a continuation in part of U.S. Pat. No.7,338,500, filed Apr. 20, 2005, entitled “INTERNAL PEDICLE INSULATORAPPARATUS AND METHOD OF USE.”

The contents of the above referenced applications are incorporatedherein by reference in their entireties.

TECHNICAL FIELD

The present technology relates generally to surgical instruments andtools. In particular, pedicle insulator assemblies and methods ofinsertion are described.

BACKGROUND

Spinal fusion typically involves the removal of damaged disc materialbetween two adjacent vertebrae and the subsequent insertion of one ormore interbody devices into the emptied disc space, either using ananterior or a posterior approach. In order to ensure primary stability,the surgeon usually adopts a fixation system that is anchored to thespine by means of orthopedic screws implanted into the pedicles of thevertebrae that are to be fused together. The single screws are connectedtogether by means of rigid or semi-rigid rods, which are convenientlyhoused within a transversal hole provided in the screw head.

Since the FDA approval of pedicle screws, approximately 200,000instrumented fusions occur each year in the US. There is very limitedtolerance between the pedicle screw and the nerve root with theinferomedial wall of the pedicle (approx. 1-2 mm). Current minimallyinvasive techniques increase risk of malposition. The pedicle screw maybe inserted off center, such as, for example, too medial, which mayimpinge on the associated nerve root causing pain. This requires arepositioning of the screw. However, even after repositioning there maybe an effect on the pedicle wall, which can still cause nerve rootirritation. Such procedures are also susceptible to loosening of thescrew.

BRIEF SUMMARY

Embodiments of the present technology are directed to an internalpedicle insulator implant assemblies and related methods. In thisregard, an exemplary embodiment of an internal pedicle insulator implantcomprises: a cylindrical wall defining an interior cavity and having afirst end and a second end, the cylindrical wall comprising a smooth,non-threaded segment, a rough surface segment, or combinations thereof.In some embodiments, one segment of the wall is of a greater thicknessthan other segments of the wall; whereby the pedicle insulator implantshields a pedicle screw that is implanted into the vertebral body andreduces nerve root irritation and diminishes the loosening of thepedicle screw.

According to a first aspect, an implant for stabilizing a surgicalfixture including: A) a proximate end and a distal end; B) asubstantially smooth channel surface symmetrically bisected by a medialaxis extending longitudinally between the proximate end and the distalend, the substantially smooth channel surface terminating at a left edgeand a right edge; C) one or more ridges symmetrically oriented along themedial axis and forming a ridge surface opposite the substantiallysmooth channel surface; D) a left teeth section extending outwardly fromthe left edge at an acute left runner angle from a horizontal planepassing through the left edge and the right edge; and E) a right teethsection extending outwardly from the right edge at an acute right runnerangle from the horizontal plane.

According to a second aspect, the implant of the first aspect or anyother aspect, wherein the left teeth section includes one or more teeth,wherein each tooth of the one or more teeth includes a generallytrapezoidal prism shape.

According to a third aspect, the implant of the first aspect or anyother aspect, wherein the ridge surface extends longitudinally betweenthe proximate end and the distal end.

According to a fourth aspect, the implant of the first aspect or anyother aspect, wherein each ridge of the one or more ridges includes afixation surface that is disposed towards the proximate end and that isoriented orthogonal to the medial axis.

According to a fifth aspect, the implant of the first aspect or anyother aspect, wherein a length of the medial axis between the proximateend and the distal end is about 15mm to 50mm.

According to a sixth aspect, the implant of the first aspect or anyother aspect, wherein the implant further includes a tip near the distalend.

According to a seventh aspect, the implant of the sixth aspect or anyother aspect, wherein the implant includes a sloped surface between aridge of the ridge section to the tip.

According to a seventh aspect, the implant of the first aspect or anyother aspect, wherein: A) the implant further includes a proximate facelocated near the proximate end of the implant, the proximate faceincluding a body section and the left teeth section and the right teethsection; B) the body section includes a curved top surface and a curvedbottom surface; C) the curved bottom surface terminates at a left endpoint and a right end point, wherein: 1) a bottom surface of the leftteeth section extends outwardly from the left end point at a left runnerangle from a horizontal plane passing through the left end point and theright end point; and 2) a bottom surface of the right teeth sectionextends outwardly from the right end point at a right runner angle fromthe horizontal plane.

According to a ninth aspect, the implant of the first aspect or anyother aspect, wherein the angle of the left runner angle isapproximately 0-30°.

According to a tenth aspect, the implant of the ninth aspect or anyother aspect, wherein the angle of the acute right runner angle issubstantially similar to the angle of the acute left runner angle.

According to an eleventh aspect, a method for stabilizing a surgicalfixture including: A) creating a void in a target site; B) deploying animplant into the void of the target site, the implant including: 1) aproximate end and a distal end; 2) a substantially smooth channelsurface symmetrically bisected by a medial axis extending longitudinallybetween the proximate end and the distal end, the substantially smoothchannel surface terminating at a left edge and a right edge; 3) one ormore ridges symmetrically oriented along the medial axis and forming aridge surface opposite the substantially smooth channel surface; and 4)wherein the implant is configured to shield a fixture, reduce nerve rootirritation, and diminish loosening of the fixture, when the fixture isimplanted into the void of the target site.

According to a twelfth aspect, the method of the eleventh aspect or anyother aspect, wherein the implant further includes: A) a left teethsection extending outwardly from the left edge at an acute left runnerangle from a horizontal plane passing through the left edge and theright edge; and B) a right teeth section extending outwardly from theright edge at an acute right runner angle from the horizontal plane.

According to a thirteenth aspect, the method of the twelfth aspect orany other aspect, wherein the one or more ridges, the left teethsection, and the right teeth section reduce a tendency of the fixture totoggle and increase a pullout strength of the fixture.

According to a fourteenth aspect, the method of the eleventh aspect orany other aspect, wherein the left teeth section includes one or moreteeth, wherein each tooth of the one or more teeth includes a generallytrapezoidal prism shape.

According to a fifteenth aspect, the method of the eleventh aspect orany other aspect, wherein: A) the ridge surface extends longitudinallybetween the proximate end and the distal end; and B) each ridge of theone or more ridges includes a fixation surface that is disposed towardsthe proximate end and that is oriented orthogonal to the medial axis.

According to a sixteenth aspect, the method of the eleventh aspect orany other aspect, wherein a length of the medial axis between theproximate end and the distal end is about 15 mm to 50 mm.

According to a seventeenth aspect, the method of the eleventh aspect orany other aspect, wherein the method further includes: A) a tip near thedistal end; and B) a sloped surface between a ridge of the ridge sectionto the tip.

According to an eighteenth aspect, the method of the eleventh aspect orany other aspect, wherein the fixture is a pedicle screw.

According to a nineteenth aspect, the method of the eleventh aspect orany other aspect, wherein the implant is in contact with the fixtureprior to and throughout deployment into the void of the target site.

According to a twentieth aspect, the method of the eleventh aspect orany other aspect, wherein the implant is deployed within the void of thetarget site prior to implantation of the fixture.

According to a twenty-first aspect, an implant for stabilizing asurgical fixture comprises an elongate body formed about an axis ofrevolution. The elongate body further comprises: a proximal end; adistal end; a channel surface extending between the proximal and distalends; a ridged surface opposite the channel surface extending betweenthe proximal and distal ends comprising one or more ridges; a firstlongitudinal runner and a second longitudinal runner adjacent thechannel surface and extending between the proximal and distal ends; afirst teeth section extending outwardly from the first longitudinalrunner comprising one or more teeth; and a second teeth sectionextending outwardly from the second longitudinal runner comprising oneor more teeth. Within the implant, the radial distance between the axisof revolution to the outermost point of the one or more teeth is greaterthan the radial distance between the axis of revolution and the apex ofthe one or more ridges.

According to a twenty-second aspect of the invention, the implant of thetwenty-first aspect of the invention comprises a channel surfaceconfigured to receive a surgical implant.

According to a twenty-third aspect of the invention, the implant of thetwenty-second aspect of the invention is configured to receive a pediclescrew.

According to a twenty-fourth aspect of the invention, the implant of thetwenty-first aspect of the invention has ridges with an ellipticalprofile.

According to a twenty-fifth aspect of the invention, the implant of thetwenty-first aspect of the invention has a tooth height of at least oneof the teeth as measured from the runner is between about 0.5 mm and 5mm.

According to a twenty-sixth aspect of the invention, the implant of thetwenty-first aspect of the invention has teeth that are shapeddifferently from the ridges.

According to a twenty-seventh aspect of the invention, the implant ofthe twenty-first aspect of the invention has teeth with a longitudinalwidth that is less than the longitudinal width of the ridges.

According to a twenty-eighth aspect of the invention, an implant forstabilizing a surgical fixture comprises an elongate body having acurved shape about its longitude. The elongate body further comprises: aproximal end; a distal end; a channel surface extending between theproximal and distal ends having a first longitudinal edge and a secondlongitudinal edge; a first runner surface adjacent to the firstlongitudinal edge and a second runner surface adjacent to the secondlongitudinal edge; a ridged surface opposite the channel surface andextending between the proximal and distal ends wherein the ridge sectioncomprises one or more ridges having a first geometry; a first teethsection extending outwardly from the first runner surface wherein thefirst tooth section comprises one or more teeth having a secondgeometry; and a second teeth section extending outwardly from the secondrunner surface, wherein the second tooth section comprises one or moreteeth having a second geometry. The second and third geometries aredifferent from the first geometry

According to a twenty-ninth aspect of the invention, within the implantof the twenty-eighth aspect of the invention, the first and second teethsections of the implant have the same geometry.

According to a thirtieth aspect of the invention, within the implant ofthe twenty-eighth aspect of the invention, the teeth in the first andsecond teeth sections of the implant have a smaller longitudinal widththan the ridges within the ridge section.

According to a thirty-first aspect of the invention, within the implantof the twenty-eighth aspect of the invention, the first and second teethsections of the implant have a greater radial height than the ridgesection.

According to a thirty-second aspect of the invention, within the implantof the twenty-eighth aspect of the invention, the faces of the teethclosest the distal end of the implant are at a different angle form thefaces of the ridges closest to the distal end of the implant relative tothe channel surface.

According to a thirty-third aspect of the invention, within the implantof the thirty-second aspect of the invention, the faces of the teethclosest to the distal end of the implant do not align with the faces ofthe ridges closes to the distal end of the implant.

According to a thirty-fourth aspect of the invention, within the implantof the thirty-second aspect of the invention, the faces of the teethclosest to the proximal end of the implant align with the faces of theridges closest to the proximal end of the implant.

According to a thirty-fifth aspect of the invention, an implant forstabilizing a surgical fixture comprises a generally elongate body ofrevolution, being revolved about an axis of revolution no more than 180degrees and having a thickness. The body further comprises: a proximalend; a distal end; a channel surface formed on the face of the bodynearest the axis of revolution; one or more ridges formed on the face ofthe body furthest from the axis of revolution; and one or more teethformed at the longitudinal edges of the body and extending away from theaxis of revolution. The teeth further comprise a first side surfaceadjacent to the channel and a second side surface opposite the firstside surface that forms a crease with the ridge section.

According to a thirty-sixth aspect of the invention, within the implantaccording to the thirty-fifth aspect of the invention, the height of theteeth from the body of the revolution is greater than the height of theridges from the body of revolution.

According to a thirty-seventh aspect of the invention, within theimplant according to the thirty-fifth aspect of the invention, the teethfurther comprise a sloping surface.

According to a thirty-eighth aspect of the invention, within the implantaccording to a thirty-seventh aspect of the invention, the slopingsurface of the teeth is nearest the distal end.

According to a thirty-ninth aspect of the invention, within the implantaccording to a thirty-eighth aspect of the invention, the ridgescomprise a sloping surface and the angle of the sloping surface of theridges is different from the angle of the sloping surface of the teeth.

According to a fortieth aspect of the invention, within the implantaccording to a thirty-ninth aspect of the invention, the teeth and theridges further comprise a flat surface normal to the channel surface.

Various embodiments of an internal pedicle insulator implant may furtherinclude, but are not limited to,: 1) a pedicle insulator, wherein thepedicle insulator may be configured to shield a pedicle screw of theabove description; 2) the pedicle insulator, wherein the pedicleinsulator may include one or more shapes (e.g., solids of revolution);3) the pedicle insulator, wherein the pedicle insulator may beconfigured to fixate its own insertion position and orientation uponinsertion into a spine; 4) the pedicle insulator, wherein the pedicleinsulator includes one or more of fixation ridges, fixation teeth, otherfixation surfaces (e.g., for the purpose of fixating position andorientation); and 5) a pedicle insulator inserter, wherein the pedicleinsulator inserter may be configured to deploy the pedicle insulator.Accordingly, it is an objective of the present technology to providevarious embodiments of an internal pedicle insulator implant assemblyfor shielding a pedicle screw that is implanted into the vertebral bodyfor reducing nerve root irritation and diminishing the loosening of thepedicle screw.

It is also another objective to provide methods for stabilizing asurgical fixture.

Other objectives and advantages of the present technology will becomeapparent from the following description taken in conjunction with theaccompanying drawings wherein are set forth, by way of illustration andexample, certain embodiments of the present technology. The drawingsconstitute a part of this specification and include exemplaryembodiments of the present technology and illustrate various objects andfeatures thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate one or more embodiments and/oraspects of the disclosure and, together with the written description,serve to explain the principles of the disclosure. The components in thedrawings are not necessarily to scale, emphasis instead being placedupon clearly illustrating the principles of the present technology.Wherever possible, the same reference numbers are used throughout thedrawings to refer to the same or like elements of an embodiment, andwherein:

FIG. 1 is a perspective view of a pedicle insulator implant assembly,according to one embodiment.

FIG. 2A is a top view showing an embodiment of a cylindrical wall,according to one embodiment.

FIG. 2B is a side view of FIG. 2A, according to one embodiment.

FIG. 2C is a top view showing another embodiment of a cylindrical wall,according to one embodiment.

FIG. 2D is a side view of FIG. 2C, according to one embodiment.

FIG. 2E is a top view showing a further embodiment of a cylindricalwall, according to one embodiment.

FIG. 2F is a side view of FIG. 2E, according to one embodiment.

FIG. 2G is a top view showing a cylindrical wall, according to oneembodiment.

FIG. 2H is a side view of FIG. 2G, according to one embodiment.

FIGS. 3A-3C are segment views showing various embodiments of a roughsegment of a cylindrical wall, according to one embodiment.

FIG. 4 is a segment view showing, according to one embodiment, acylindrical wall with a longitudinal slot extending from a first end toa second end, and having one segment of the cylindrical wall thickerthan the other.

FIG. 5 is a segment view showing, according to one embodiment, acylindrical wall having one segment of the cylindrical wall smooth andthicker in width as compared to an opposing segment which is rough andthinner in width. The smooth thicker segment is placed to protect thenerve from the pedicle screw.

FIG. 6 is a perspective view of an exemplary pedicle insulator,according to one embodiment.

FIG. 7 is a side view of an exemplary pedicle insulator, according toone embodiment.

FIG. 8 is a perspective view of an exemplary pedicle insulator,according to one embodiment.

FIG. 9 is a back view of an exemplary pedicle insulator, according toone embodiment.

FIG. 10 is a bottom view of an exemplary pedicle insulator, according toone embodiment.

FIG. 11 is a top view of an exemplary pedicle insulator, according toone embodiment.

FIG. 12 is a perspective view of an exemplary pedicle insulator inserterwith pedicle insulator, according to one embodiment.

FIG. 13 is a top view of an exemplary pedicle insulator inserter,according to one embodiment.

FIG. 14 is a bottom view of an exemplary pedicle insulator inserter withpedicle insulator, according to one embodiment.

FIG. 15 is a perspective view of an exemplary pedicle insulatorinserter, according to one embodiment.

FIG. 16 is a front view of an exemplary pedicle insulator inserter,according to one embodiment.

FIG. 17 is a back view of an exemplary pedicle insulator inserter,according to one embodiment.

FIG. 18 is a top view of an exemplary pedicle insulator inserter,according to one embodiment.

FIG. 19 is a bottom view of an exemplary pedicle insulator inserter,according to one embodiment.

FIG. 20 is a side view of an exemplary pedicle insulator inserter,according to one embodiment.

FIG. 21 is a side view of an exemplary pedicle insulator inserter,according to one embodiment.

FIG. 22 is a perspective view of an exemplary pedicle insulatorinserter, according to one embodiment.

FIG. 23 is a partial perspective view of an exemplary pedicle insulatorinserter, according to one embodiment.

FIG. 24 is a bottom view of an exemplary pedicle insulator inserter,according to one embodiment.

FIG. 25 is a perspective view of an exemplary pedicle insulator andinserter, according to one embodiment.

FIG. 26 is a perspective view of an exemplary pedicle insulator andinserter, according to one embodiment.

FIG. 27 is a perspective view of an exemplary pedicle insulator andinserter, according to one embodiment.

FIG. 28 is a top view of an exemplary pedicle insulator and inserter,according to one embodiment.

FIG. 29 is a bottom view of an exemplary pedicle insulator and inserter,according to one embodiment.

FIG. 30 is a back view of an exemplary pedicle insulator and inserter,according to one embodiment.

FIG. 31 is a front view of an exemplary pedicle insulator and inserter,according to one embodiment.

FIG. 32 is a side view of an exemplary pedicle insulator and inserter,according to one embodiment.

FIG. 33 is a side view of an exemplary pedicle insulator and inserter,according to one embodiment.

DETAILED DESCRIPTION

For the purpose of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings and specific language will be used todescribe the same. It will, nevertheless, be understood that nolimitation of the scope of the disclosure is thereby intended; anyalterations and further modifications of the described or illustratedembodiments, and any further applications of the principles of thedisclosure as illustrated therein are contemplated as would normallyoccur to one skilled in the art to which the disclosure relates. Alllimitations of scope should be determined in accordance with and asexpressed in the claims.

Whether a term is capitalized is not considered definitive or limitingof the meaning of a term. As used in this document, a capitalized termshall have the same meaning as an uncapitalized term, unless the contextof the usage specifically indicates that a more restrictive meaning forthe capitalized term is intended. However, the capitalization or lackthereof within the remainder of this document is not intended to benecessarily limiting unless the context clearly indicates that suchlimitation is intended.

Any incorporation by reference is not intended to give a definitive orlimiting meaning of a particular term. In the case of a conflict ofterms, this document governs.

FIGS. 1-5 are described in:

U.S. patent application Ser. No. 16/511,946, filed Jul. 15, 2019,entitled “INTERNAL PEDICLE INSULATOR,” which is a continuation of U.S.patent application Ser. No. 15/975,308, filed May 9, 2018, now U.S. Pat.No. 10,390,860, entitled “INTERNAL PEDICLE INSULATOR,” which is acontinuation of U.S. patent application Ser. No. 14/723,620, filed May28, 2015, now U.S. Pat. No. 9,993,268, entitled “INTERNAL PEDICLEINSULATOR” which claims the benefit of and priority to U.S. ProvisionalPatent Application No. 62/003,978, entitled “INTERNAL PEDICLEINSULATOR”, filed May 28, 2014; and

U.S. patent application Ser. No. 11/712,257, filed Feb. 28, 2007, nowU.S. Pat. No. 8,728,132, entitled “INTERNAL PEDICLE INSULATOR APPARATUSAND METHOD OF USE,” which is a continuation in part of U.S. Pat. No.7,338,500, filed Apr. 20, 2005, entitled “INTERNAL PEDICLE INSULATORAPPARATUS AND METHOD OF USE.”

The above referenced applications, including descriptions therein of theFIGS. 1-5 , are incorporated herein by reference in their entireties.

FIG. 6 illustrates a pedicle insulator 600. In various embodiments, thepedicle insulator 600 may include one or more shapes, wherein the one ormore shapes may be solids of revolution. In one or more embodiments, thepedicle insulator 600 may be fabricated through additive manufacturingmethods, such as 3D printing, through injection molding methods, throughmachining methods, or through a combination of methods. In at least oneembodiment, the pedicle insulator 600 may include one or more materialsincluding, but not limited to, 1) polyetheretherketone (PEEK); 2)titanium, and/or derivatives thereof; 3) stainless steel; 4) aluminum;5) cobalt-chrome; 6) nickel alloy; 7) polyphenylsulfone (PPSU); 8)polysulfone (PSU); and 9) other materials suitable for use in additivemanufacturing methods. In some embodiments, the pedicle insulator 600may include one or more porous structures. For example, the one or moreporous structures may be porous structures fabricated (e.g., 3D-printed,machined, or molded) from implant grade titanium and cobalt chromiumalloy. In various embodiments, physical dimensions and geometry of thepedicle insulator 600 and any feature thereof may be determined, inpart, by a geometry of an associated pedicle screw, a geometry of anassociated insertion area (e.g., a pedicle insertion hole), and/or othergeometric factors.

In various embodiments, the pedicle insulator 600 includes a proximateend 601 and a distal end 607. In one or more embodiments, the pedicleinsulator 600 includes, but it not limited to, at least one teethsection 605. In at least one embodiment, the pedicle insulator 600includes two of the teeth section 605. In various embodiments, the atleast one teeth section 605 includes at least one tooth 613. In one ormore embodiments, the tooth 613 may include a generally trapezoidalprism shape. Thus, the tooth 613 may include at least six surfaces,wherein at least one surface (e.g., a base surface) may be obfuscatedand/or otherwise formed into the pedicle insulator 600.

In various embodiments, the tooth 613 may further include an outer toothsurface 617, wherein the orientation of the outer tooth surface 617 maybe parallel to the insertion direction of the exemplary pedicleinsulator. In various embodiments, the tooth 613 may include a taperedtooth surface 615, wherein the tapered tooth surface 615 may begenerally oriented obtuse (e.g., in an interior angle) to the outertooth surface 617. Orientation of the tapered tooth surface 615 isfurther illustrated herein in FIG. 22 . In one or more embodiments, thetooth 613 includes a fixating tooth surface 619, wherein the orientationof the fixating tooth surface 619 may be orthogonal to the insertiondirection of the exemplary pedicle insulator. In at least oneembodiment, the orthogonal orientation of the fixating tooth surface 619may increase the magnitude of a pullout force (e.g., in a directionparallel and opposite to the insertion direction) required to remove theexemplary pedicle insulator.

In various embodiments, the tooth 613 may include an outerchannelization tooth surface 621, wherein the orientation of the outerchannelization tooth surface 621 may be parallel to the insertiondirection of the exemplary pedicle insulator. In one or moreembodiments, the tooth 613 may further include an inner channelizationtooth surface, such as is later illustrated in FIG. 8 . In variousembodiments, both inner and outer channelization surfaces may permit oneor more exemplary pedicle insulators to fixate and secure theirrespective insertion position by increasing frictional forces along therespective inner and outer channelization surfaces.

In various embodiments, the pedicle insulator 600 may include at leastone tooth gap 623. In one or more embodiments, the gap 623 may includethe space of the runner 805, illustrated in FIG. 8 , between the end ofa tapered tooth surface 615 and the beginning of a fixating toothsurface 619. In at least one embodiment, the teeth section 605 includesa plurality of teeth 613 (such as, for example, 2-40 teeth 613) and aplurality of gaps 623 (such as, for example, 2-40 gaps 623).

In various embodiments, wherein the teeth section 605 includes teeth 613and gaps 623. One or more of the teeth 613 and one or more of the gaps623 may be located in a specific and repeated manner (e.g., within theteeth section 605). In one or more embodiments, the teeth section 605may include, but is not limited to: 1) a fixed displacement distancebetween each of the one or more teeth located therein (e.g., teeth 613);2) a fixed displacement distance between the one or more gaps locatedtherein (e.g., gaps 623); and 3) determination of the above fixeddisplacement distances via alternating placement of one tooth followedimmediately by placement of one gap. At least one embodiment of theabove described arrangement may be illustrated in the teeth section 605of FIG. 6 .

In various embodiments, the pedicle insulator 600 may include aproximate face 603, wherein the proximate face 603 may be located at theproximate end 601. In one or more embodiments, the surface of theproximate face 603 may be flat and oriented orthogonal to the insertiondirection of the exemplary pedicle insulator.

In various embodiments, the pedicle insulator 600 may include a tip 609.In at least one embodiment, the tip 609 may be located at the distal end607. In one or more embodiments, the tip 609 may be located adjacent tothe at least one teeth section 605. In various embodiments, the distalsurface of the tip 609 may be generally flat. In at least oneembodiment, the tip 609 further includes a tapered tip surface 611,wherein the direction of the tapered tip surface 611 (e.g., the taperdirection) may be towards the distal end 607. In various embodiments,the tip 609 includes a generally curved wall, wherein the generallycurved wall may include a tapering thickness.

In various embodiments, the tip 609 may include at least one tipfixation surface 625. In at least one embodiment, the tip fixationsurface 625 may be oriented in a manner such that the magnitude of apullout force (e.g., in a direction parallel and opposite to theinsertion direction) required to remove the exemplary pedicle insulatoris increased. In one or more embodiments, one or more of the tipfixation surface 625 may be placed at one or more locations along thetip 609. In at least one embodiment, FIG. 6 illustrates two respectiveplacements of the tip fixation surface 625.

In at least one embodiment, the pedicle insulator 600 includes a medialaxis 627. In one or more embodiments, the medial axis is orthogonal tothe proximate face 603. In various embodiments, the pedicle insulator600 may be symmetrically bisected along the medial axis 627.

FIG. 7 illustrates a side view of an exemplary pedicle insulator 700. Invarious embodiments, the exemplary pedicle insulator 700 includes aridge 701. In one or more embodiments, a ridge section 703 includes oneor more ridges (e.g., ridges 701). In at least one embodiment, the ridgesection 703 may include 2-7 ridges. In various embodiments, the ridgesection 703 may be symmetrically oriented along the medial axis 627 ofthe pedicle insulator 600, each illustrated in FIG. 6 .

In various embodiments, the ridge 701 may include a ridge fixationsurface configured to increase the magnitude of a pullout force (e.g.,in a direction parallel and opposite to the insertion direction)required to remove the pedicle insulator. In at least one embodiment,the fixation surface may be the fixation surface 1105 of FIG. 11 ,further described later herein.

In various embodiments, the ridge 701 includes a ridge bottom point 711and a ridge apex 713. In various embodiments, the ridge 701 includes aridge height 705. In at least one embodiment, the ridge height 705 maybe between about 0.1 mm and about 2.0 mm. In various embodiments, theridge height 705 may be determined by a ridge slope angle 707. In one ormore embodiments, the ridge slope angle 707 may refer to the anglebetween the apex 713 and the bottom point 711. In at least oneembodiment, the ridge projection angle 707 may be between about 5° andabout 45°. In various embodiments, the ridge 701 includes a ridge length709. In at least one embodiment, the ridge length 709 may be betweenabout 0.25 mm and about 5 mm. In at least one embodiment the ridgelength 709 may measure between about 0.01-0.5 mm, between about 0.5-1.0mm, between about 1.0-1.5 mm, between about 1.5-2.0 mm, between about2.0-2.5 mm, between about 3.0-3.5 mm, between about 3.5-4.0 mm, betweenabout 4.5-5.0 mm, between about 5.0-5.5 mm, or between about 5.5-6.0 mm.

FIG. 8 illustrates a pedicle insulator 800. In one or more embodiments,the pedicle insulator 800 includes a channel 801. In at least oneembodiment, the channel 801 may present a specific opening angle, suchas one or more opening angles further illustrated in FIGS. 10 and 11 .

In at least one embodiment, the pedicle insulator 800 includes a medialaxis 809. In one or more embodiments, the medial axis is orthogonal to aproximate face of the pedicle insulator 800 (e.g., such as the proximateface 603 illustrated in FIG. 6 ). In various embodiments, the pedicleinsulator 800 may be symmetrically bisected along the medial axis 809.In various embodiments, the channel 801 may be symmetrically orientedalong the medial axis 809.

In at least one embodiment, the surface of the channel 801 may be smoothand may include a semi-circular shape. In one or more embodiments, thechannel 801 presents a geometry that conforms to a generally cylindricalgeometry of a pedicle screw. The channel 801, presenting a smoothsurface and a conformational geometry may precisely and accuratelydirect insertion of a pedicle screw to a target implantation sitewithout disrupting pedicle screw insertion or increasing pedicle screwinsertion force. In at least one embodiment, the channel 801 may preventdamage by the pedicle screw (e.g., due to edges of the screw and/or ascrew tip) to surrounding tissue, because the channel 801 may preciselyand accurately direct insertion of the pedicle screw to the targetimplantation site.

In various embodiments, the pedicle insulator 800 may include one ormore inner channelization surfaces 803 included on an exemplary tooth,such as the tooth 613 of FIG. 6 . In one or more embodiments, the innerchannelization surface 803 may be oriented parallel to an outerchannelization surface, such as the outer channelization tooth surface621 of FIG. 6 . In at least one embodiment, the inner channelizationsurface may be oriented parallel to the insertion direction of theexemplary pedicle insulator. In various embodiments, the pedicleinsulator 800 may include a number of inner channelization surfaces 803equal to a number of teeth included on the pedicle insulator 600, eachillustrated in FIG. 6 .

In one or more embodiments, the pedicle insulator 800 may include arunner 805. In various embodiments, the pedicle insulator 800 mayinclude two runners. In at least one embodiment, the runner 805 maydiffuse biomechanical and other stresses experienced by one or moresections of the exemplary pedicle insulator; in particular, the runner805 may diffuse stresses experienced by teeth included in the exemplarypedicle insulator. In various embodiments, the runner 805 may be locatedadjacent to the channel 801 and may be oriented parallel to the medialaxis 809.

In one or more embodiments, the pedicle insulator 800 may include alength 807, wherein the length 807 refers to an overall length of theexemplary pedicle insulator. In various embodiments, the pedicleinsulator length 807 may be standardized across iterations of thepedicle insulator and/or may be determined on a case by case basis. Inat least one embodiment, the pedicle insulator length 807 may be betweenabout 15 mm and about 50 mm. In at least one embodiment the pedicleinsulator length 807 may measure between about 10-15 mm, between about15-20 mm, between about 20-25 mm, between about 25-30 mm, between about30-35 mm, between about 35-40 mm, between about 40-45 mm, between about45-50 mm, or between about 50-55 mm.

FIG. 9 illustrates a pedicle insulator 900. In various embodiments, thepedicle insulator 900 includes a runner thickness 901. In one or moreembodiments, the runner thickness 901 may refer to a thickness of therunner 805 illustrated in FIG. 8 . In at least one embodiment, therunner thickness 901 may contribute to the diffusion of biomechanicaland or other stresses experienced by one or more teeth located on arunner. In one or more embodiments, the runner thickness 901 may bebetween about 0.5 mm and about 5 mm. In at least one embodiment therunner thickness 901 may measure between about 0.01-0.5 mm, betweenabout 0.5-1.0 mm, between about 1.0-1.5 mm, between about 1.5-2.0 mm,between about 2.0-2.5 mm, between about 3.0-3.5 mm, between about3.5-4.0 mm, between about 4.5-5.0 mm, between about 5.0-5.5 mm, orbetween about 5.5-6.0 mm.

In at least one embodiment, the pedicle insulator 900 may include atooth outer surface 921, a tooth taper surface 923, a tooth gap 925, atip 927 and a tapered tip surface 929. In one or more embodiments, thedimensions, properties, geometries and orientations of the tooth outersurface 921, the tooth taper surface 923, the gap 925, the tip 927 andthe tapered tip surface 929 may be substantially similar to likefeatures described herein in reference to other drawing figures.

In various embodiments, the pedicle insulator 900 includes a tooth bodylength 903. In one or more embodiments, the tooth body length 903 maygenerally refer to a length of the tooth outer surface 921. In at leastone embodiment, the tooth body length 903 does not include the length ofthe tooth tapered surface 923. In some embodiments, the tooth bodylength 903 may be between about 0.1 mm and about 3 mm. In at least oneembodiment the tooth body length 903 may measure between about 0.01-0.1mm, between about 0.1-0.3 mm, between about 0.3-0.5 mm, between about0.5-0.7 mm, between about 0.7-0.9 mm, between about 0.9-1.1 mm, betweenabout 1.1-1.3 mm, between about 1.3-1.5 mm, between about 1.5-1.7 mm,between about 1.7-1.9 mm, between about 1.9-2.1 mm, between about2.1-2.3 mm, between about 2.3-2.5 mm, between about 2.5-2.7 mm, betweenabout 2.7-2.9 mm, between about 2.9-3.1 mm, or between about 3.1-3.3 mm.

In various embodiments, the pedicle insulator 900 includes a tooth gaplength 905. In one or more embodiments, the tooth gap length 905 maygenerally refer to a length of the gap 925. In at least one embodiment,the tooth gap length does not include the length of the tooth taperedsurface 923. In some embodiments, the tooth gap length 905 may bebetween about 0.1 mm and about 3 mm. In at least one embodiment thetooth gap length 905 may measure between about 0.01-0.1 mm, betweenabout 0.1-0.3 mm, between about 0.3-0.5 mm, between about 0.5-0.7 mm,between about 0.7-0.9 mm, between about 0.9-1.1 mm, between about1.1-1.3 mm, between about 1.3-1.5 mm, between about 1.5-1.7 mm, betweenabout 1.7-1.9 mm, between about 1.9-2.1 mm, between about 2.1-2.3 mm,between about 2.3-2.5 mm, between about 2.5-2.7 mm, between about2.7-2.9 mm, between about 2.9-3.1 mm, or between about 3.1-3.3 mm.

In various embodiments, the pedicle insulator 900 includes a toothtapered surface length 907. In one or more embodiments, the toothtapered surface length 907 may refer to a length (e.g., oriented asillustrated in FIG. 9 ) between an initiating taper point 931 and aterminating taper point 933 of the tooth tapered surface 923. In someembodiments, the tooth tapered surface length 907 may be between about0.1 mm and about 2 mm. In at least one embodiment the tooth taperedsurface length 907 may measure between about 0.01-0.1 mm, between about0.1-0.3 mm, between about 0.3-0.5 mm, between about 0.5-0.7 mm, betweenabout 0.7-0.9 mm, between about 0.9-1.1 mm, between about 1.1-1.3 mm,between about 1.3-1.5 mm, between about 1.5-1.7 mm, between about1.7-1.9 mm, between about 1.9-2.1 mm, or between about 2.1-2.3 mm.

In various embodiments, the pedicle insulator 900 includes a tooth taperangle 909. In one or more embodiments, the tooth taper angle 909 maygenerally refer to an exterior angle between the tooth outer surface 921and the tooth tapered surface 923. In at least one embodiment, the toothtaper angle 909 may be between about 5° and about 45°.

In various embodiments, the pedicle insulator 900 may include a tip wallinitial thickness 911. In one or more embodiments, the tip wall initialthickness 911 may include the sum of the runner thickness 901 and aheight of a tooth (e.g., as described further herein). In at least oneembodiment, the tip wall initial thickness 911 may refer to a thicknessof the curved wall (not illustrated in FIG. 9 ) of the tip 927 prior totapering. In various embodiments, the tip wall initial thickness 911 maybe greater than the runner thickness 901. In one or more embodiments,the tip wall initial thickness 911 may be between about 0.5 mm and about5 mm. In at least one embodiment the tip wall initial thickness 911 maymeasure between about 0.01-0.5 mm, between about 0.5-1.0 mm, betweenabout 1.0-1.5 mm, between about 1.5-2.0 mm, between about 2.0-2.5 mm,between about 3.0-3.5 mm, between about 3.5-4.0 mm, between about4.5-5.0 mm, between about 5.0-5.5 mm, or between about 5.5-6.0 mm.

In various embodiments, the pedicle insulator 900 may include a tip wallterminal thickness 913. In one or more embodiments, the tip wallterminal thickness 913 may refer to a thickness of the curved wall (notillustrated in FIG. 9 ) of the tip 927 at the conclusion of tapering. Invarious embodiments, the tip wall terminal thickness 913 may be lessthan the runner thickness 901 and may be less than the height of onetooth. In one or more embodiments, the tip wall terminal thickness 913may be between about 0.5 mm and about 5 mm. In at least one embodimentthe tip wall terminal thickness 913 may measure between about 0.01-0.5mm, between about 0.5-1.0 mm, between about 1.0-1.5 mm, between about1.5-2.0 mm, between about 2.0-2.5 mm, between about 3.0-3.5 mm, betweenabout 3.5-4.0 mm, between about 4.5-5.0 mm, between about 5.0-5.5 mm, orbetween about 5.5-6.0 mm.

In various embodiments, the pedicle insulator 900 may include a tiptaper angle 915. In one or more embodiments, the tip taper angle 915 mayrefer to an exterior angle between one of the outer tooth surface 921and one of the tapered tip surface 929. In at least one embodiment, thetip taper angle 915 may be between about 5° and about 45°. In one ormore embodiments, the tip taper angle may be less than the tooth taperangle 909.

In various embodiments, the pedicle insulator 900 may include a tiplength 917. In one or more embodiments, the tip length 917 may refer toa length of the tip 927. In at least one embodiment, the tip length 917may be between about 1 mm and about 15 mm. In at least one embodimentthe tip length 917 may measure between about 0.01-2.0 mm, between about2.0-4.0 mm, between about 4.0-6.0 mm, between about 6.0-8.0 mm, betweenabout 8.0-10.0 mm, between about 10.0-12.0 mm, between about 12.0-14.0mm, or between about 14.0-16.0 mm.

In various embodiments, the pedicle insulator 900 may include a toothheight 919. In one or more embodiments, the tooth height 919 may referto a height of a tooth (e.g., as described elsewhere herein). In atleast one embodiment, the tooth height 919 may be between about 0.5 mmand about 5 mm. In at least one embodiment the tooth height 919 maymeasure between about 0.01-0.5 mm, between about 0.5-1.0 mm, betweenabout 1.0-1.5 mm, between about 1.5-2.0 mm, between about 2.0-2.5 mm,between about 3.0-3.5 mm, between about 3.5-4.0 mm, between about4.5-5.0 mm, between about 5.0-5.5 mm, or between about 5.5-6.0 mm. Invarious embodiments, the tooth height 919 may be equal to a height of apedicle screw thread.

FIG. 10 illustrates a pedicle insulator 1000. In various embodiments,the pedicle insulator 1000 includes an opening angle 1001. In one ormore embodiments, a magnitude of the opening angle 1001 may be about120°, about 180°, or one or more other magnitudes. In at least oneembodiment, the magnitude of the opening angle 1001 may be determined,in part, by a geometry of an associated pedicle screw, a geometry of anassociated insertion area (e.g., a pedicle insertion hole), and/or othergeometric factors.

In various embodiments, the pedicle insulator 1000 includes an innerradius 1003. In one or more embodiments, a magnitude of the inner radius1003 may be about 2.25 mm, about 2.75 mm, about 3.25 mm, about 3.5 mm,or one or more other magnitudes. In at least one embodiment the innerradius 1003 may measure between about 1.75-2.0 mm, between about2.0-2.25 mm, between about 2.25-2.50 mm, between about 2.5-2.75 mm,between about 2.75-3.0 mm, between about 3.0-3.25 mm, between about3.25-3.5 mm, between about 3.5-3.75 mm, between about 3.75-4.0 mm, orbetween about 4.0-4.25 mm. In at least one embodiment, the magnitude ofthe inner radius 1003 may be determined, in part, by a geometry of anassociated pedicle screw, a geometry of an associated insertion area(e.g., a pedicle insertion hole), and/or other geometric factors.

In various embodiments, the pedicle insulator 1000 includes an outerradius 1005. In one or more embodiments, a magnitude of the outer radius1005 may be about 2.5 mm, or one or more other magnitudes. In at leastone embodiment the outer radius 1005 may measure between about 1.75-2.0mm, between about 2.0-2.25 mm, between about 2.25-2.50 mm, between about2.5-2.75 mm, between about 2.75-3.0 mm, between about 3.0-3.25 mm,between about 3.25-3.5 mm, between about 3.5-3.75 mm, between about3.75-4.0 mm, between about 4.0-4.25 mm, between about 4.25-4.5 mm,between about 4.5-4.75 mm, or between about 4.75-5.0 mm. In at least oneembodiment, the magnitude of the outer radius 1005 may be determined bya combination of one or more other measurement factors including, butnot limited to: 1) the opening angle 1001; 2) the inner radius 1003; and3) a tip terminal wall thickness, such as the tip terminal wallthickness 913 of FIG. 9 .

FIG. 11 illustrates a pedicle insulator 1100. In at least oneembodiment, the pedicle insulator 1100 may include a ridge 1111, arunner 1113, an opening angle 1115, an inner radius 1117 and an outerradius 1119. In one or more embodiments, the dimensions, properties,geometries and orientations of the ridge 1111, the runner 1115, theopening angle 1115 and the inner radius 1117 may be substantiallysimilar to similar features described herein. In at least oneembodiment, a magnitude of the outer radius 1119 may be about 2.5 mm. Inat least one embodiment the outer radius 1119 may measure between about1.75-2.0 mm, between about 2.0-2.25 mm, between about 2.25-2.50 mm,between about 2.5-2.75 mm, between about 2.75-3.0 mm, between about3.0-3.25 mm, between about 3.25-3.5 mm, between about 3.5-3.75 mm,between about 3.75-4.0 mm, between about 4.0-4.25 mm, between about4.25-4.5 mm, between about 4.5-4.75 mm, or between about 4.75-5.0 mm. Insome embodiments, the magnitude of the outer radius 1119 may bedetermined by a combination of one or more other measurement factorsincluding, but not limited to: 1) the opening angle 1115; and 2) theinner radius 1117.

In various embodiments, the pedicle insulator 1100 includes a runnerheight 1101. In one or more embodiments, the runner height 1101 maydescribe a height of the runner 1113 and may also describe a width of atooth (e.g., as described elsewhere herein). In at least one embodiment,a magnitude of the runner height 1101 may be between about 0.5 mm andabout 5 mm. In at least one embodiment the runner height 1101 maymeasure between about 0.01-0.5 mm, between about 0.5-1.0 mm, betweenabout 1.0-1.5 mm, between about 1.5-2.0 mm, between about 2.0-2.5 mm,between about 3.0-3.5 mm, between about 3.5-4.0 mm, between about4.5-5.0 mm, between about 5.0-5.5 mm, or between about 5.5-6.0 mm. Insome embodiments, the magnitude of the runner height 1101 may bedependent, in part, upon the respective magnitudes of the inner radius1117 and outer radius 1119.

In various embodiments, the pedicle insulator 1100 includes a runnerangle 1103. In one or more embodiments, the runner angle 1103 may referto the angle between a surface of the runner 1113 and a horizontalplane, wherein the exemplary pedicle insulator of the pedicle insulator1100 lies immediately beneath the plane. In at least one embodiment, amagnitude of the runner angle 1103 may be between about 0° and about60°. In one or more embodiments, the magnitude of the runner angle 1103may be selected such that the runner height 1101 is greater than 0 mm.

In various embodiments, the pedicle insulator 1100 includes a ridgefixation surface 1105. In one or more embodiments, the ridge fixationsurface 1105 may be a fixation surface of the ridge 1111. In at leastone embodiment, the ridge fixation surface 1105 may be orientedorthogonal to the insertion direction of a pedicle insulator. In variousembodiments, the orientation of the ridge fixation surface 1105increases manner the magnitude of a pullout force (e.g., in a directionparallel and opposite to the insertion direction) required to remove theexemplary pedicle insulator.

In various embodiments, the pedicle insulator 1100 includes a ridgewidth 1107. In one or more embodiments, the ridge width 1107 may referto a width of the ridge 1111. In at least one embodiment, a magnitude ofthe width 1107 may be about 2.3 mm, about 4.5 mm, about 5.3 mm, about6.2 mm, about 6.5 mm, or one or more other magnitudes. In at least oneembodiment the ridge width 1107 may measure between about 1.0-1.5 mm,between about 1.5-2.0 mm, between about 2.0-2.5 mm, between about2.5-3.0 mm, between about 3.0-3.5 mm, between about 3.5-4.0 mm, betweenabout 4.0-4.5 mm, between about 4.5-5.0 mm, between about 5.5-6.0 mm,between about 6.0-6.5, between about 6.5-7.0, or between about 7.0-7.5mm.

In various embodiments, the pedicle insulator 1100 includes a pedicleinsulator width 1109. In one or more embodiments, a magnitude of thepedicle insulator width 1109 may be determined by a combination of oneor more other measurement factors including, but not limited to: 1) theopening angle 1115; 2) the inner radius 1117; and 3) the ridge width1119. In at least one embodiment, the magnitude of the pedicle insulatorwidth 1109 may be about 4.9 mm, about 7.9 mm, about 8.3 mm, about 9.7mm, or one or more other magnitudes.

FIG. 12 illustrates a pedicle insulator inserter 1200, referred toherein as an “inserter.” In various embodiments, an inserter provides amechanism for deploying a pedicle insulator 1201 to a target site (e.g.,on or within a body). In at least one embodiment, the inserter 1200 maydeploy the pedicle insulator 1201 from a distal end 1203. In one or moreembodiments, the inserter 1200 includes a guide rod 1205, wherein thepedicle insulator 1201, prior to and during deployment, rests along theguide rod 1205. Thus, the guide rod 1205 may include a relativelycylindrical geometry, wherein a diameter of the relatively cylindricalgeometry may be based on an outer radius of the pedicle insulator 1201.In some embodiments, the guide rod 1205 may include materials including,but not limited to, stainless steel, or one or more other materialssuitable for use in a surgical environment. In at least one embodiment,the guide rod 1205 may include a rod length (not illustrated) that maybe substantial similar to a length of the inserter 1200.

Continuing with FIG. 12 , in various embodiments, the inserter 1200includes a first shaft section 1207. In at least one embodiment, thefirst shaft section 1207 includes an elliptical cross section. Thus, (asillustrated in FIG. 14 and further described herein) the cross sectionof the first shaft section 1207 may present a semi-major axis and asemi-minor axis (e.g., that is of lesser magnitude than the semi-majoraxis). One of ordinary skill in the art will understand that asemi-major axis is a longest diameter of an ellipse, thus the semi-majoraxis is a line segment that runs through the center and both foci of anellipse. One of ordinary skill in the art will further understand that asemi-minor axis refers to a diameter that is orthogonal to thesemi-major axis and also runs through the center of the ellipse. In someembodiments, the first shaft section 1207 may be integrally formed withone or more components of the inserter 1200. In at least one embodiment,when the inserter 1200 is in a non-deployed state, the insulator 1201may be substantially recessed within the first shaft section 1207.

In one or more embodiments, the inserter 1200 includes a second shaftsection 1211. In at least one embodiment, the second shaft section 1211includes a substantially circular cross section. In some embodiments,the second shaft section 1211 may be integrally formed with one or morecomponents of the inserter 1200. In various embodiments (as describedfurther herein), the circular cross section of the second shaft section1211 may present a diameter that is equal in length to the semi-majoraxis of the first shaft section 1207. In at least one embodiment, in anon-deployed state, the second shaft section 1211 may partially containthe pedicle insulator 1201 and may substantially contain the guide rod1205. As illustrated in FIG. 12 , in a deployed state, the second shaftsection 1211 may substantially contain the guide rod 1205.

In at least one embodiment, the pedicle inserter 1200 includes a shafttaper section 1209 that is disposed between the first shaft section 1207and the second shaft section 1211. In one or more embodiments, the tapersection 1209 initially presents (e.g., towards the proximate end 1217) asubstantially circular cross section that is congruent to the circularcross section of the second shaft section 1211. In at least oneembodiment, the taper section 1209 presents (e.g., towards the distalend 1203) a substantially elliptical cross section that is congruent tothe elliptical cross section of the first shaft section 1207.

In various embodiments, the taper section 1209 tapers (from circular toelliptical) as the section progresses toward the distal end 1203. Thus,towards the proximate end 1217, the taper section 1209 may present acircular cross section (e.g., with a single diameter) and, towards thedistal end 1203, may present an elliptical cross section. As illustratedin FIG. 12 , the initial circular cross section, having a singlediameter, may smoothly deform (e.g., taper) into an elliptical crosssection, having a semi-major axis and a semi-minor axis. Thus, invarious embodiments, the shaft taper section 1209 may function as ageometric transition zone between the first shaft section 1207 and thesecond shaft section 1211.

In various embodiments, the inserter 1200 includes a handle 1213. In atleast one embodiment, the handle 1213 (e.g., as illustrated in FIG. 12 )may be disposed between the second shaft section 1211 and a proximateend 1217. In one or more embodiments, the handle 1213 may include amostly rectangular prismatic geometry, and may further include (e.g., asdescribed later herein) one or more features, which may improve a user'sability to grip and/or otherwise interact with the handle 1213. In atleast one embodiment, the handle 1213 may be designed in a manner suchthat a user can precisely and accurately orient the inserter 1200 to atarget site.

In some embodiments, the inserter 1200 may include a strike plate 1219located near the proximate end 1217. In one or more embodiments, thestrike plate 1219 may present a substantially flat top surface (notillustrated in FIG. 12 ) that is configured to receive a striking force(e.g., from a mallet or the like) and transfer the force intotranslational movement of the guide rod 1205 and pedicle insulator 1201through the first shaft 1211 and second shaft 1207 and out the distalend 1203 of the inserter 1200. In various embodiments, the strike plate1219 forms or defines a pin-hole 1215 that may function as a componentin a grenade-pin configuration which may prevent deployment of theinserter 1200 and insulator 1201. Thus, when a pin (not illustrated) isinserted into the pin-hole 1215 (e.g., while the strike-plate 1219 isdrawn upwards from the inserter 1200), movement of the strike plate 1219may be restricted.

As shown FIG. 12 , the inserter 1200 is in a deployed state. In variousembodiments, in the deployed state, the pin-hole 1215 may be devoid of apin (e.g., as illustrated in FIG. 12 ) and the strike plate 1219 may bedepressed towards the distal end 1203 and handle 1213. In at least oneembodiment, in the deployed state, the guide rod 1205 may be partiallydisposed from the distal end 1205 and the pedicle insulator 1203 may besubstantially or fully disposed from the distal end 1205 (e.g., as aresult of strike plate position).

In one or more embodiments, in a non-deployed state, the inserter 1200may house the pedicle insulator 1201 and a substantial length of theguide rod 1205 within the first shaft section 1207 and the second shaftsection 1211. In at least one embodiment, in the non-deployed state, thestrike plate 1219 may be drawn upwards from the inserter 1200 andtowards the proximate end 1217. Thus, the guide rod 1205 and pedicleinsulator 1201 may be recessed within the inserter 1200 as a result ofthe strike plate 1219 being drawn upwards. In at least one embodiment,in the non-deployed state, a pin is placed within the pin-hole 1215,thus restricting movement of the strike plate 1215.

Deployment of the pedicle insulator 1201 from the inserter 1200 to atarget site may include, but is not limited to: 1) loading the pedicleinsulator 1201 onto the guide rod 1205; 2) withdrawing the guide rod1205 and pedicle insulator 1201 into the inserter 1200; 3) placing a pininto the pin hole 1215; 4) upon being required in a surgery, orientingthe inserter; 5) removing the pin from the pin hole 1215; and 6)striking a strike plate, thereby deploying the pedicle insulator 1205into a patient.

FIG. 13 illustrates a pedicle insulator inserter 1300. In variousembodiments, the inserter 1300 includes a handle 1301 and a strike plate1305. In at least one embodiment, the strike plate 1305 may function asa target site for one or more striking motions, which may deploy apedicle insulator from the inserter 1300. In one or more embodiments,the strike plate 1305 may include a grenade-pin mechanism, including apin hole (e.g., for example, as is illustrated in FIG. 12 ) and a pin(not illustrated herein), for preventing accidental deployment. In someembodiments, the handle 1301 may include at least one curved edge 1303providing an ergonomic gripping and/or handling surface.

In various embodiments, the handle 1301 may include at least oneorientation indicator 1307. In one or more embodiments, the indicator1307 may include a raised, impressed, or otherwise permanent demarcationcontaining textual and/or symbolic information relating to operation ofthe inserter 1300 (e.g., an arrow). In at least one embodiment, theindicator 1307 may present information indicating directionality of apedicle insulator loaded within the inserter 1300.

FIG. 14 illustrates a pedicle insulator inserter 1400. In variousembodiments, the inserter 1400 includes a first shaft section 1401. Inone or more embodiments, the first shaft section 1401 may include a wallthickness 1403, which may be sized based on one or more dimensions of apedicle insulator 1405 (e.g., as illustrated in FIG. 14 within the firstshaft section 1401). In at least one embodiment, the first shaft section1401 may include a baseplate 1407, wherein the base plate 1407 may bedisposed at the end of the first shaft section 1401. In someembodiments, the base plate 1407 may include an elliptical shape,wherein a profile of the pedicle insulator 1405 and a guide rod arecarved through the baseplate 1407. Thus, the pedicle insulator 1405 anda guide rod may pass through the baseplate 1407 (e.g., upon deploymentof the pedicle insulator as described above, or otherwise).

In at least one embodiment, the first shaft section 1401 may include anelliptical cross section. One of ordinary skill in the art willunderstand that dimensions of an elliptical cross section may be definedby a length of the elliptical cross section's semi-minor and semi-majoraxes. One of ordinary skill in the art will further understand that: 1)the semi-major axis refers to a longest diameter of an ellipse (e.g.,the elliptical cross section) that is a line segment that runs from thecenter of the ellipse to a perimeter of the ellipse (e.g., at a widestpoint of the ellipse); 2) the semi-minor axis refers to a line segmentthat runs from the center of the ellipse and is orthogonal to thesemi-major axis. Thus, in various embodiments, the first shaft section1401 includes a semi-minor axis length 1409 and a semi-major axis length1411. In one or more embodiments, the semi-minor length 1409 andsemi-major length 1411 may be dimensioned to accommodate passage of thepedicle insulator 1405 (e.g., during both loading into and deploymentfrom the inserter 1400) through the baseplate 1407. Thus, the dimensionsof the first shaft section 1401 may be sized in a manner such that thepedicle insulator 1405 may pass through an interior of the shaft section1401 (e.g., both into and out of the inserter 1400).

FIGS. 15-21 illustrate an additional embodiment of a pedicle insulatorinserter. As described in greater detail below, a pedicle insulator maybe secured to the inserter and delivered into a target site (inparticular, a void thereof).

FIG. 22 illustrates a pedicle insulator inserter 2200. In variousembodiments, the inserter 2200 may be manufactured from materialsincluding, but not limited to, stainless steel, or one or more othermaterials suitable for use in a surgical environment. In at least oneembodiment, the inserter 2200 may be disposable or may be suitable forre-use following sterilization techniques such as autoclaving.

In various embodiments, the inserter 2200 includes a proximal end 2201.In one or more embodiments, the inserter 2200 further includes aconnector 2203 located at the proximal end 2201. In at least oneembodiment, the connector 2203 may be an attachment point for aquick-connect apparatus (for example, an AO quick-connect apparatus).Thus, the connector 2203 may facilitate simplified and rapid attachmentof any apparatus (e.g., handles, etc.) that also include quick-connectattachment features.

In various embodiments, the inserter 2200 includes a primary shaft 2205,which is generally cylindrical in shape. In one or more embodiments, theprimary shaft 2205 includes a primary shaft length 2207. In at least oneembodiment, the primary shaft length 2207 may measure between about50-300 mm or about 120-140 mm. In various embodiments, the primary shaftlength 2207 may measure between about 50-100 mm, between about 100-150mm, between about 150-200 mm, between about 200-250 mm, between about250-300 mm, or between about 300-350 mm. In at least one embodiment, theprimary shaft length 2207 may be selected to accommodate placement of apedicle insulator (e.g., into a patient) and/or to accommodate aparticular surgical approach to pedicle insulator placement. In one ormore embodiments, the primary shaft length 2207 may be further selectedto accommodate patient anatomy (e.g., dimensions thereof). For example,a particular patient may present a larger than average anatomy;accordingly, a primary shaft length 2207 may be selected to compensatefor the larger anatomy (e.g., a longer primary shaft length 2207 may beselected).

In various embodiments, the inserter 2200 includes a distal end 2209 anda tip 2211 located near the distal end 2209. In one or more embodiments,the tip 2211 may be filleted. Per the present disclosure, filletedrefers to geometric features of the tip 2211 that are substantiallydevoid of projecting edges and points, and present at least one curvedsurface. In one or more embodiments, the use of curved geometries andthe minimization of projecting edges may reduce a capacity of the tip2211 to puncture tissue (e.g., compared to a tip presenting straight andpointed geometries). Thus, the tip 2211 may be filleted in a manner suchthat a minimum magnitude of force required to puncture tissue isincreased (compared to a minimum force required to puncture tissue usinga non-filleted tip). In at least one embodiment, the tip 2211 mayinclude edges that are chamfered, rounded or otherwise blunted in amanner such that a minimum magnitude of force required to laceratetissue may be increased (e.g., compared to a minimum force required tolacerate tissue using a non-blunted tip).

In at least one embodiment, filleting of the tip 2211 may improve easeof orientation and insertion of the inserter 2200 into a target site.For example, a non-filleted tip (e.g., presenting a more substantiallysquare-cross section) may be more likely, due to its angular geometry,to collide with an edge of a substantially circular target site. Thus, amore angular tip geometry may increase a likelihood that, uponorientation of the inserter, the tip will strike an edge of a targetsite. Furthermore, in the same example, because the non-filleted tipdoes not include filleted surfaces (e.g., that may bias the insertertowards placement into the target site), the filleted-tip may requirefurther orientation before successful insertion into the target site canbe achieved.

In contrast, in the same example, a filleted tip may be less likely tocollide with an edge of the substantially circular target site, becausethe filleted tip presents a less angular geometry. Furthermore, if thefilleted tip does come into contact with an edge of the target site,filleted surfaces of the tip may bias the inserter towards placementinto the target site, because the filleted surfaces may be angled suchthat a path of least resistance is a path further into the target site.Thus, the tip 2211 may be filleted for purposes including, but notlimited to: 1) reducing likelihood of an inserter striking an edge of atarget site (e.g., in a manner that impedes further placement of theinserter); and 2) biasing an inserter such that a path of leastresistance (e.g., from a perspective of the tip 2211) is further into atarget site.

In one or more embodiments, the inserter 2200 includes a secondary shaft2213. In at least one embodiment, the secondary shaft 2213 may bedisposed between the tip 2209 and the primary shaft 2205. In someembodiments, the tip 2209 and the secondary shaft 2213 may be integrallyformed. In one embodiment, the tip 2209, secondary shaft 2213 andprimary shaft 2205 may be integrally formed. In various embodiments, thesecondary shaft 2213 may include a recess 2215 (e.g., which is describedfurther herein and further illustrated in FIG. 23 ). In one or moreembodiments, the recess 2215 temporarily secures a pedicle insulator tothe inserter 2200 via a press-fit interface. In at least one embodiment,the secondary shaft 2213 further includes a secondary shaft length 2217that may measure between about 10-50 mm or 30-34 mm. In variousembodiments, the secondary shaft length 2217 may measure between about10-15 mm, between about 15-20 mm, between about 20-25 mm, between about25-30 mm, between about 30-35 mm, between about 35-40 mm, between about45-50 mm, between about 50-55 mm, or between about 55-60 mm.

FIG. 23 illustrates an inserter recess 2300 of a pedicle insulatorinserter. In various embodiments, the recess 2300 houses and secures apedicle insulator within the inserter. In one or more embodiments, therecess 2300 includes an overhang 2301. In at least one embodiment theoverhang 2301 includes an overhang length 2303 which may measure betweenabout 3.0-5.0 mm. In various embodiments, the overhang length 2301 maymeasure between about 2.5-3.0 mm, between about 3.0-3.5 mm, betweenabout 3.5-4.0 mm, between about 4.0-4.5 mm, between about 4.5-5.0 mm, orbetween about 5.0-5.5 mm.

In various embodiments, the recess 2300 includes a back-plate 2305. Inat least one embodiment, the back-plate 2305 may include a geometricprofile that is substantially congruous to a geometric profile of thetop of a pedicle insulator (e.g., as illustrated in FIG. 11 ). Thus, inone or more embodiments, the top of a pedicle insulator that has beenloaded into the inserter (e.g., and slid into the recess 2300) may be insubstantially conformed contact with the back-plate 2305.

In one or more embodiments, the recess 2300 includes a loading surface2307 that may also form a surface of the inserter secondary shaft (e.g.,as illustrated in FIG. 22 ). In at least one embodiment, the loadingsurface 2307 may include a geometric profile that is substantiallycongruous to a geometric profile of the back of a pedicle insulator(e.g., as can be observed in FIG. 8 ). Thus, in various embodiments, theback of a pedicle insulator that has been loaded into the inserter maybe in substantially conformed contact with the loading surface 2307.

In various embodiments, the recess 2300 includes a fin 2309 (e.g., oneor more fins 2309). In at least one embodiment, the fin 2309 providesfrictional forces to secure loading of a pedicle insulator into theinserter (e.g., more specifically, into the recess 2300). In one or moreembodiments, the recess 2300 includes a plurality of fins 2309 (such as,for example, between about 2-20). In some embodiments, the fin 2309includes a fin length 2311 that may measure between about 1-3 mm. In atleast one embodiment the fin length 2311 may measure between about0.01-0.1 mm, between about 0.1-0.3 mm, between about 0.3-0.5 mm, betweenabout 0.5-0.7 mm, between about 0.7-0.9 mm, between about 0.9-1.1 mm,between about 1.1-1.3 mm, between about 1.3-1.5 mm, between about1.5-1.7 mm, between about 1.7-1.9 mm, between about 1.9-2.1 mm, betweenabout 2.1-2.3 mm, between about 2.3-2.5 mm, between about 2.5-2.7 mm,between about 2.7-2.9 mm, between about 2.9-3.1 mm, or between about3.1-3.3 mm.

In various embodiments, the fin 2309 includes a tapered surface 2313. Inat least one embodiment, the tapered surface 2313 guides loading of apedicle insulator into the recess 2300. In various embodiments, upon andafter loading, one or more fins 2309 press the pedicle insulator intothe loading surface 2307, thereby generating frictional forces thatsecure the pedicle insulator within the recess 2300 and atop the loadingsurface 2307. Thus, the pedicle insulator may be secured within therecess 2300 and atop the loading surface 2307 by means of a press fitinitiated and maintained by the one or more fins 2309.

FIG. 24 illustrates a pedicle insulator inserter 2400. In one or moreembodiments, the inserter 2400 includes a fin 2401 and a first findistance 2403. In at least one embodiment, the first fin distance 2403may represent a distance between a bottom of the fin 2401 and a loadingsurface (as illustrated in FIG. 23 ). In various embodiments, the firstfin distance 2403 may measure between about 1-1.5 mm. In at least oneembodiment the first fin distance 2403 may measure between about 0.7-0.8mm, between about 0.8-0.9 mm, between about 0.9-1.0 mm, between about1.0-1.1 mm, between about 1.2-1.3 mm, between about 1.4-1.5 mm, betweenabout 1.5-1.6 mm, between about 1.7-1.8 mm, between about 1.8-1.9 mm,between about 1.9-2.0 mm, or between about 2.0-2.1 mm. In someembodiments, a magnitude of the first fin distance 2403 may bedetermined by and substantially conform to an outer radius of a pedicleinsulator (for example, outer radius 1119 illustrated in FIG. 11 ). Inone or more embodiments, the fin distance 2403 may be sized in a mannersuch that one or more fins 2401 generate frictional forces of a specificmagnitude upon receipt of a pedicle insulator into the inserter 2400(e.g., into a recess of the inserter 2400). In at least one embodiment,the fin distance 2403 may be sized in a manner such that the generatedfrictional forces are of a magnitude that is less than a magnitude of ana force generated by one or more fixation features (e.g., teeth andridges described herein) of a deployed pedicle insulator in response toa pullout force. Thus, the fin distance 2403 may be sized such that thepedicle insulator is held securely in place, but may be dislodged fromthe inserter 2400 (e.g., by means of a pullout force and correspondingopposing force) upon deployment into a target site.

In various embodiments, the inserter 2400 further includes a second findistance 2405 that may represent a distance between a top of the fin2401 and the loading surface. In at least one embodiment, the second findistance 2405 may measure between about 1-2 mm. In at least oneembodiment the second fin distance 2405 may measure between about0.9-1.0 mm, between about 1.0-1.1 mm, between about 1.1-1.2 mm, betweenabout 1.2-1.3 mm, between about 1.3-1.4 mm, between about 1.4-1.5 mm,between about 1.5-1.6 mm, between about 1.7-1.8 mm, between about1.8-1.9 mm, or between about 1.9-2.0 mm. In one or more embodiments, thesecond fin distance 2405 may be determined by a thickness of a pedicleinsulator. In at least one embodiment, the second fin distance 2405 maybe sized in a manner such that a recess and the loading surface of theinserter 2400 may accommodate a pedicle insulator. Thus, in variousembodiments, the second fin distance 2405 may be sized in a manner suchthat a pedicle insulator may be loaded into a recess of the inserter2400, but also (upon being loaded) engage in a frictional interactionwith one or more fins 2401 to secure the pedicle insulator within therecess and atop a loading surface.

In various embodiments, the inserter 2400 includes a radius 2407. In oneor more embodiments, the radius 2407 may measure between about 2-4 mm.In at least one embodiment the radius 2407 may measure between about1.7-2.0 mm, between about 2.0-2.3 mm, between about 2.3-2.7 mm, betweenabout 2.7-3.0 mm, between about 3.0-3.3 mm, between about 3.3-3.7 mm,between about 3.7-4.0 mm, or between about 4.0-4.3 mm. In at least oneembodiment, a magnitude of the radius 2407 may be determined by, andsubstantially conform to, an outer radius of a pedicle insulator. Invarious embodiments, the fin 2401 includes a fin width 2409 that maymeasure between about 0.1-1 mm. In at least one embodiment the fin width2409 may measure between about 0.01-0.1 mm, between about 0.1-0.2 mm,between about 0.2-0.3 mm, between about 0.4-0.5 mm, between about0.5-0.6 mm, between about 0.6-0.7 mm, between about 0.7-0.8 mm. betweenabout 0.8-0.9 mm, between about 0.9-1.0 mm, or between about 1.0-1.1 mm.In one or more embodiments, the inserter 2400 further includes asecondary shaft width 2411. In at least one embodiment, the width 2411may refer to a width of an inserter secondary shaft (e.g., asillustrated in FIG. 22 ) and a width of an inserter recess (e.g., asillustrated in FIG. 23 ).

FIG. 25 illustrates a pedicle insulator apparatus 2500. In variousembodiments, the apparatus 2500 includes an inserter 2501 and a pedicleinsulator 2503. In one or more embodiments, the pedicle insulator 2503is secured on a loading surface and within a recess of the inserter2501. In at least one embodiment, the apparatus 2500 may be provided toa user (e.g., a surgeon) as shown (e.g., with the insulator 2503 alreadyloaded). In some embodiments, the apparatus 2500 may be provided to theuser as part of a kit, the kit further including an additional 2-20insulators 2503 (e.g., which may be loaded into the inserter 2501 anddelivered to one or more target sites throughout a surgery). In at leastone embodiment, the kit and apparatus 2500 may be subject to one or moresterilization treatments (e.g., prior to being provided to a user).

FIG. 26 illustrates a pedicle insulator apparatus 2600. In one or moreembodiments, the apparatus 2600 includes an inserter 2601 and a pedicleinsulator 2605. In at least one embodiment, a user deploys the insulator2605 from the inserter 2601 by sliding the insulator 2605 from a recess2603 located within a secondary shaft of the inserter 2601. For example,a user may orient the apparatus 2600 within a target site and apply apulling force (e.g., to dislodge and deploy the insulator 2605 from therecess 2603 and inserter 2601). In the same example, one or more teethsections and other fixations features (e.g., described earlier herein)may provide a resistive force (e.g., in opposition to the pulling force)sufficient to dislodge the insulator 2605 from the recess 2603 and,thereby, deploy the insulator 2605 to the target site.

FIGS. 27-31 illustrate additional embodiments of a pedicle insulatorinserter described herein. In at least one embodiment, the pedicleinsulator inserter illustrated in FIGS. 27-31 may be the same orsubstantially similar to the pedicle insulator inserter illustrated inFIGS. 15-26 . As described herein, a pedicle insulator may be secured tothe inserter and delivered to, on, or within a body.

Conclusion

While various aspects have been described in the context of a preferredembodiment, additional aspects, features, and methodologies of theclaimed inventions will be readily discernible from the descriptionherein, by those of ordinary skill in the art.

Many embodiments and adaptations of the disclosure and claimedinventions other than those herein described, as well as manyvariations, modifications, and equivalent arrangements andmethodologies, will be apparent from or reasonably suggested by thedisclosure and the foregoing description thereof, without departing fromthe substance or scope of the claims. Furthermore, any sequence(s)and/or temporal order of steps of various processes described andclaimed herein are those considered to be the best mode contemplated forcarrying out the claimed inventions. It should also be understood that,although steps of various processes may be shown and described as beingin a preferred sequence or temporal order, the steps of any suchprocesses are not limited to being carried out in any particularsequence or order, absent a specific indication of such to achieve aparticular intended result. In most cases, the steps of such processesmay be carried out in a variety of different sequences and orders, whilestill falling within the scope of the claimed inventions. In addition,some steps may be carried out simultaneously, contemporaneously, or insynchronization with other steps.

The embodiments were chosen and described in order to explain theprinciples of the claimed inventions and their practical application soas to enable others skilled in the art to utilize the inventions andvarious embodiments and with various modifications as are suited to theparticular use contemplated. Alternative embodiments will becomeapparent to those skilled in the art to which the claimed inventionspertain without departing from their spirit and scope. Accordingly, thescope of the claimed inventions is defined by the appended claims ratherthan the foregoing description and the exemplary embodiments describedtherein.

We claim:
 1. An implant for stabilizing a surgical fixture comprising:an elongate body formed about an axis of revolution, wherein theelongate body further comprises a proximal end; a distal end; a channelsurface extending between the proximal and distal ends; a ridged surfaceopposite the channel surface extending between the proximal and distalends comprising one or more ridges; a first longitudinal runner and asecond longitudinal runner adjacent the channel surface and extendingbetween the proximal and distal ends; a first teeth section extendingoutwardly from the first longitudinal runner comprising one or moreteeth; and a second teeth section extending outwardly from the secondlongitudinal runner comprising one or more teeth, wherein the radialdistance between the axis of revolution to the outermost point of theone or more teeth is greater than the radial distance between the axisof revolution and the apex of the one or more ridges.
 2. The implant ofclaim 1, wherein the channel surface is configured to receive a surgicalimplant.
 3. The implant of claim 2, wherein the implant is a pediclescrew.
 4. The implant of claim 1, wherein the ridges have an ellipticalprofile.
 5. The implant of claim 1, wherein the tooth height of at leastone of the teeth as measured from the runner is between about 0.5 mm and5 mm.
 6. The implant of claim 1, wherein the shape of the teeth isdifferent from the shape of the ridges.
 7. The implant of claim 1,wherein the longitudinal width of the teeth is less than thelongitudinal width of the ridges.
 8. An implant for stabilizing asurgical fixture comprising: an elongate body having a curved shapeabout its longitude, the elongate body further comprising: a proximalend; a distal end; a channel surface extending between the proximal anddistal ends having a first longitudinal edge and a second longitudinaledge; a first runner surface adjacent to the first longitudinal edge anda second runner surface adjacent to the second longitudinal edge; aridged surface opposite the channel surface and extending between theproximal and distal ends wherein the ridge section comprises one or moreridges having a first geometry; a first teeth section extendingoutwardly from the first runner surface wherein the first tooth sectioncomprises one or more teeth having a second geometry; and a second teethsection extending outwardly from the second runner surface wherein thesecond tooth section comprises one or more teeth having a secondgeometry; wherein the second and third geometries are different from thefirst geometry.
 9. The implant of claim 8, wherein the first and secondteeth sections have the same geometry.
 10. The implant of claim 8,wherein the teeth in the first and second teeth sections have a smallerlongitudinal width than the ridges within the ridge section.
 11. Theimplant of claim 8, wherein the first and second teeth sections have agreater radial height than the ridge section.
 12. The implant of claim8, wherein the faces of the teeth closest the distal end of the implantare at a different angle form the faces of the ridges closest to thedistal end of the implant relative to the channel surface.
 13. Theimplant of claim 12, wherein the faces of the teeth closest to thedistal end of the implant do not align with the faces of the ridgescloses to the distal end of the implant.
 14. The implant of claim 12,wherein the faces of the teeth closest to the proximal end of theimplant align with the faces of the ridges closest to the proximal endof the implant.
 15. An implant for stabilizing a surgical fixturecomprising: a generally elongate body of revolution, being revolvedabout an axis of revolution no more than 180 degrees and having athickness, wherein the body further comprises: a proximal end; a distalend; a channel surface formed on the face of the body nearest the axisof revolution; one or more ridges formed on the face of the bodyfurthest from the axis of revolution; and one or more teeth formed atthe longitudinal edges of the body and extending away from the axis ofrevolution, wherein the teeth further comprise a first side surfaceadjacent to the channel and a second side surface opposite the firstside surface that forms a crease with the ridge section.
 16. The implantof claim 15, wherein the height of the teeth from the body of revolutionis greater than the height of the ridges from the body of revolution.17. The implant of claim 15, wherein the teeth further comprise asloping surface.
 18. The implant of claim 17, wherein the slopingsurface of the teeth is nearest the distal end.
 19. The implant of claim18, wherein the ridges comprise a sloping surface and the angle of thesloping surface of the ridges is different from the angle of the slopingsurface of the teeth.
 20. The implant of claim 19, wherein the teeth andthe ridges further comprise a flat surface normal to the channelsurface.